FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S
K Number: K063013
·
Decision Dec 1, 2006
Classifications
1
FEI Numbers
224
Registration Numbers
224
Same Product Code
34
Applicant Total
3
Review Days
60
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Basic Information
- Device Name
- PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S
- K Number
- K063013
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aearo Company
- Date Received
- October 2, 2006
- Decision Date
- December 1, 2006
- Product Code
- MSH
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MSH | Respirator, Surgical | FDA class 2 | General, Plastic Surgery |
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